Provention Plans Two-Phase Launch Of Tzield, Pricing Drug Higher Than Expected

At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.

Provention won FDA approval for Tzield, its drug to delay onset of stage 3 type 1 diabetes • Source: Shutterstock

Provention Bio, Inc. plans to launch Tzield (teplizumab-mzwv) for delaying onset of stage 3 type 1 diabetes (T1D) in two phases, starting with those in stage 2 with a familial history of the disease before branching into the stage 2 population more broadly. Although labeling does not carry a family-history restriction, the company has identified that segment as the “most addressable” for the initial launch. The drug’s price point came in significantly higher than analysts had anticipated, but its monopoly on the approved indication makes it unlikely payers will set restrictions.

The US Food and Drug Administration granted full approval to Tzield on 17 November, for use in patients who currently...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Novo And Lilly Lay Out Patient Segmentation Plans For Obesity Treatment

 

As competition heats up and the obesity market matures, the two frontrunners are tailoring their studies to the wants and needs of different patient groups.

Vertex Heralds ‘Unprecedented’ Zimislecel Type 1 Diabetes Data

 
• By 

The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.